On January 6, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for 89Zr-HuMab-5B1, the Company’s fully human antibody product, as a new generation PET scan cancer imaging agent (Press release, MabVax, JAN 6, 2016, View Source [SID:1234508673]). Schedule your 30 min Free 1stOncology Demo! Subject to FDA authorization to proceed, MabVax plans to initiate the Phase I clinical trial in patients with pancreatic cancer in early 2016.
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The 89Zr-HuMab-5B1 imaging agent has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of pancreatic cancer patients and an attractive companion diagnostic for the HuMab-5B1 therapeutic product. In December 2015, MabVax received the FDA’s authorization to proceed with HuMab-5B1 in a Phase I trial as a therapeutic treatment for patients with pancreatic cancer.
This second planned Phase I trial will evaluate the safety, pharmacokinetics and biodistribution of 89Zr-HuMab-5B1 in cancer patients. The trial will also determine the ideal dose and conditions for an optimal PET scan image using the new imaging agent.
David Hansen, MabVax’s President and Chief Executive Officer, said, "With the submission of this second IND in late December, we have achieved our objective of filing both INDs for our HuMab-5B1 based products during 2015. We are making preparations to begin the Phase I trial with HuMab-5B1 as a therapeutic agent and, subject to FDA authorization to proceed with this second clinical trial, will begin dosing our first patients in the 89Zr-HuMab-5B1 Phase I trial soon thereafter."
"We anticipate that the Phase I trial with 89Zr-HuMab-5B1 will produce an initial set of images by mid-year 2016. This will be an important interim milestone in our continued development of this diagnostic product and could have a positive impact on our future commercial and corporate development activities. We expect to complete patient enrollment in this trial before the end of 2016," added Mr. Hansen. "We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab-5B1, as well as with follow-on antibodies under development at MabVax."
About HuMab-5B1:
MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the HuMab-5B1 antibody demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.